WASHINGTON, DC – After repeated requests for cooperation and months of delay, Republican leaders of the House Energy and Commerce Committee today set a final deadline for the Food and Drug Administration to provide documents relevant to the deadly meningitis outbreak and the agency’s history with the New England Compounding Center (NECC)
Committee Leaders Set Final Deadline for FDA to Provide Documents Related to Deadly Meningitis OutbreakFebruary 1, 2013 | Press Release
Excerpt: The few communications FDA has produced to the committee from the account of one district office employee raise new and troubling questions about the agency’s oversight of NECC after the December 2006 Warning Letter up until the recent outbreak, including why FDA failed to re-inspect the company’s facility. FDA’s repeated inaction is even more troubling in that it runs counter to remarks you gave early in your tenure during a speech entitled, ‘Effective Enforcement and Benefit
To read EPA's February 1, 2013, response, click here. To read the committee's December 12, 2012, letter, click here.
Pitts, Cassidy, Grassley, Hatch, Alexander, Enzi Seek Details of Long-overdue Attention to Federal Discount Prescription Drug ProgramJanuary 31, 2013 | Press Release
WASHINGTON, DC – Reps. Joe Pitts and Bill Cassidy and Sens. Chuck Grassley, Orrin Hatch, Lamar Alexander and Michael Enzi today sought details of the federal government’s long-overdue attention to the qualification of the participants in a federal discount prescription drug program.
Excerpt: By its inaction, HRSA essentially turned a blind eye to entities who no longer should have been participating in the 340B program, allowing them to improperly reap the benefits of deeply discounted 340B drugs. Only last year did HRSA finally begin to ensure that participants continued to be eligible. … Maintaining the integrity of the 340B program is of the upmost importance, and we trust that you share our concerns.
To read the letter, click here.